Combination Chemotherapy Followed by Radiation Therapy in Treating Children With Localized Ependymoma
NCT ID: NCT00004224
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
1999-01-31
2008-03-31
Brief Summary
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PURPOSE: This phase II trial is studying combination chemotherapy and radiation therapy to see how well they work in treating children with localized ependymoma.
Detailed Description
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* Determine the event free and overall survival of children with incompletely resected localized ependymoma when treated with adjuvant cyclophosphamide, etoposide, and vincristine followed by radiotherapy.
* Determine the response rate in these patients to this regimen.
OUTLINE: This is a multicenter study.
Patients undergo surgery to remove as much of tumor as possible. Patients with residual disease proceed to chemotherapy, while those with no residual disease proceed directly to radiotherapy.
Chemotherapy begins within 3 weeks of surgery and consists of vincristine IV on days 1, 8, and 15, cyclophosphamide IV over 3 hours on day 1, and etoposide IV over 4 hours on days 1-3. Treatment repeats every 4 weeks for up to 4 courses. Patients who progress after 2 courses proceed to radiotherapy. If residual disease is still present at completion of chemotherapy, second look surgery is recommended.
Patients undergo radiotherapy daily for 6 weeks beginning after complete resection within 4 weeks of surgery, within 3 weeks of completion of chemotherapy, or within 4 weeks of second look surgery.
Patients are followed at 6 weeks after radiotherapy, every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 2-3 years.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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cyclophosphamide
etoposide
vincristine sulfate
adjuvant therapy
conventional surgery
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically proven nonmetastatic intracranial ependymoma
* Cellular
* Papillary
* Clear cell
* Mixed cell
* Anaplastic
* No myxopapillary ependymoma, subependymoma, or ependymoblastoma
PATIENT CHARACTERISTICS:
Age:
* 3 to 20
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* No hematologic disease that would preclude study participation
Hepatic:
* Not specified
Renal:
* No renal disease that would preclude study participation
Other:
* No concurrent unrelated disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Prior steroids allowed
Radiotherapy:
* No prior radiotherapy
Surgery:
* Not specified
3 Years
20 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Italian Association for Pediatric Hematology Oncology
OTHER
Societe Internationale d'Oncologie Pediatrique
OTHER
Principal Investigators
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Richard Grundy, MD, PhD
Role: STUDY_CHAIR
Birmingham Children's Hospital
Maura Massimino, MD
Role: STUDY_CHAIR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Locations
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Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia
Buenos Aires, Buenos Aires, Argentina
Hospital for Sick Children
Toronto, Ontario, Canada
Fondazione Istituto Nazionale dei Tumori
Milan, , Italy
Erasmus MC - Sophia Children's Hospital
Rotterdam, , Netherlands
Hospital Des Cruces
Vizcaya, , Spain
Ostra Sjukhuset
Gothenburg, , Sweden
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Countries
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Other Identifiers
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SIOP-EPENDYMOMA-99
Identifier Type: -
Identifier Source: secondary_id
AIEOP-EPENDYMOMA-99
Identifier Type: -
Identifier Source: secondary_id
CCLG-EPENDYMOMA-99
Identifier Type: -
Identifier Source: secondary_id
EU-99001
Identifier Type: -
Identifier Source: secondary_id
CDR0000067465
Identifier Type: -
Identifier Source: org_study_id